MAUDE Adverse Event Report: ABBOTT IRELAND ALINITY I HBSAG QUALITATIVE II REAGENT KIT; TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM)

Model Number	08P1021
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed false reactive alinity i hbsag results generated on an alinity i processing module for two patients that confirmed positive and were negative on an other method.The following information was provided: sid (b)(6) initial result = 1.35 s/co, repeat results = 1.25 s/co and 1.33 s/co; hbsag confirmatory results: c1 = 0.35 s/co, c2=1.86 s/co, neut% = 94%.Sample was sent to reference lab and came back negative on unknown methodology.Sid (b)(6) initial result = 2.63 s/co, repeat results = 2.74 s/co and 2.72 s/co; hbsag confirmatory results: c2 = 2.31 s/co, neut% = 97% no impact to patient management was reported.
Additional Manufacturer Narrative
Patient identifier: sid (b)(6) and sid (b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Additional Manufacturer Narrative
The complaint investigation included review of data and information provided by the customer, search for similar complaints, ticket and trending review, labeling review, device history review, and inhouse testing of a retained reagent lot 33169fn00.Return testing was not completed as returns were not available.Data and information provided by the customer was reviewed and support the complaint issue without indication for any additional issue.The lot search review did not identify an increase in complaint activity for the issue of false reactive results.The ticket and trending review for the complaint list number did not identify any trends.Device history review in did not identify any nonconformances or deviations associated with the complaint lot and the customer¿s issue.Performance testing was performed using an in-house retained kit of the complaint lot.Acceptance criteria was met indicating the lot is performing as expected.A review of the labeling adequately addresses the customer¿s issue.Based on the investigation, no systemic issue or deficiency with the alinity i hbsag qualitative ii reagent, lot 33169fn00, was identified.

• Brand Name: ALINITY I HBSAG QUALITATIVE II REAGENT KIT
• Common Device Name: TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM)
• Manufacturer (Section D): ABBOTT IRELAND; finisklin business park; sligo F91VY 44; EI F91VY44
• Manufacturer (Section G): ABBOTT IRELAND; finisklin business park; sligo F91VY 44; EI F91VY44
• Manufacturer Contact: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 14458054
• Report Number: 3008344661-2022-00053
• Device Sequence Number: 4570280
• Product Code: LOM
• UDI-Device Identifier: 00380740136581
• UDI-Public: 00380740136581
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P110029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/15/2022
• Device Model Number: 08P1021
• Device Catalogue Number: 08P10-21
• Device Lot Number: 33169FN00
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/04/2022
• Supplement Date Received by Manufacturer: 07/15/2022
• Initial Report FDA Received Date: 05/20/2022
• Supplement Report FDA Received Date: 07/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/29/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ALINI HBSAG QUA CONF US, 08P11-21, 32390FN00; ALINI HBSAG QUA CONF US, 08P11-21, 32390FN00; ALNTY I PROCESSING MODU, 03R65-01, (B)(6) ; ALNTY I PROCESSING MODU, 03R65-01, (B)(6)
• Patient Sex: Unknown